Dialysis system having display with electromagnetic compliance (&#34;emc&#34;) seal

ABSTRACT

A medical machine includes: an enclosure defining an opening, at least a portion of the enclosure being electrically conductive and acting as a first capacitor plate; a medical device component located inside the enclosure; a window placed adjacent to the opening; a video display with an at least partially conductive case acting as a second capacitor plate; and a dielectric member placed between the first and second capacitor plates, the plates and dielectric member forming a capacitor configured to prevent leakage of electromagnetic energy from the enclosure.

BACKGROUND

In general, the present disclosure relates to medical fluid deliverysystems that employ a pumping cassette. In particular, the presentdisclosure provides systems, methods and apparatuses for cassette-baseddialysis medical fluid therapies, including but not limited to thoseusing peristaltic pumps and diaphragm pumps.

Due to various causes, a person's renal system can fail. Renal failureproduces several physiological derangements. The balance of water,minerals and the excretion of daily metabolic load is no longer possibleand toxic end products of nitrogen metabolism (urea, creatinine, uricacid and others) can accumulate in blood and tissue.

Kidney failure and reduced kidney function have been treated withdialysis. Dialysis removes waste, toxins and excess water from the bodythat would otherwise have been removed by normal functioning kidneys.Dialysis treatment for replacement of kidney functions is critical tomany people because the treatment is life-saving.

Hemodialysis and peritoneal dialysis are two types of dialysis therapiesused commonly to treat loss of kidney function. Hemodialysis treatmentutilizes the patient's blood to remove waste, toxins and excess waterfrom the patient. The patient is connected to a hemodialysis machine andthe patient's blood is pumped through the machine. Catheters areinserted into the patient's veins and arteries so that blood can flow toand from the hemodialysis machine. The blood passes through a dialyzerof the machine, which removes waste, toxins and excess water from theblood. The cleaned blood is returned to the patient. A large amount ofdialysate, for example about 120 liters, is consumed to dialyze theblood during a single hemodialysis therapy. Hemodialysis treatment lastsseveral hours and is generally performed in a treatment center aboutthree or four times per week.

Peritoneal dialysis uses a dialysis solution, or “dialysate,” which isinfused into a patient's peritoneal cavity via a catheter. The dialysatecontacts the peritoneal membrane of the peritoneal cavity. Waste, toxinsand excess water pass from the patient's bloodstream, through theperitoneal membrane and into the dialysate due to diffusion and osmosis,i.e., an osmotic gradient occurs across the membrane. The spentdialysate is drained from the patient, removing waste, toxins and excesswater from the patient. This cycle is repeated.

There are various types of peritoneal dialysis therapies, includingcontinuous ambulatory peritoneal dialysis (“CAPD”), automated peritonealdialysis (“APD”), tidal flow APD and continuous flow peritoneal dialysis(“CFPD”). CAPD is a manual dialysis treatment. The patient manuallyconnects an implanted catheter to a drain, allowing spent dialysatefluid to drain from the peritoneal cavity. The patient then connects thecatheter to a bag of fresh dialysate, infusing fresh dialysate throughthe catheter and into the patient. The patient disconnects the catheterfrom the fresh dialysate bag and allows the dialysate to dwell withinthe peritoneal cavity, wherein the transfer of waste, toxins and excesswater takes place. After a dwell period, the patient repeats the manualdialysis procedure, for example, four times per day, each treatmentlasting about an hour. Manual peritoneal dialysis requires a significantamount of time and effort from the patient, leaving ample room forimprovement.

Automated peritoneal dialysis (“APD”) is similar to CAPD in that thedialysis treatment includes drain, fill, and dwell cycles. APD machines,however, perform the cycles automatically, typically while the patientsleeps. APD machines free patients from having to manually perform thetreatment cycles and from having to transport supplies during the day.APD machines connect fluidly to an implanted catheter, to a source orbag of fresh dialysate and to a fluid drain. APD machines pump freshdialysate from a dialysate source, through the catheter, into thepatient's peritoneal cavity, and allow the dialysate to dwell within thecavity, and allow the transfer of waste, toxins and excess water to takeplace. The source can be multiple sterile dialysate solution bags.

APD machines pump spent dialysate from the peritoneal cavity, though thecatheter, to the drain. As with the manual process, several drain, filland dwell cycles occur during APD. A “last fill” occurs at the end ofCAPD and APD, which remains in the peritoneal cavity of the patientuntil the next treatment.

Both CAPD and APD are batch type systems that send spent dialysis fluidto a drain. Tidal flow systems are modified batch systems. With tidalflow, instead of removing all of the fluid from the patient over alonger period of time, a portion of the fluid is removed and replacedafter smaller increments of time.

Continuous flow, or CFPD, systems clean or regenerate spent dialysateinstead of discarding it. The systems pump fluid into and out of thepatient, through a loop. Dialysate flows into the peritoneal cavitythrough one catheter lumen and out another catheter lumen. The fluidexiting the patient passes through a reconstitution device that removeswaste from the dialysate, e.g., via a urea removal column that employsurease to enzymatically convert urea into ammonia. The ammonia is thenremoved from the dialysate by adsorption prior to reintroduction of thedialysate into the peritoneal cavity. Additional sensors are employed tomonitor the removal of ammonia. CFPD systems are typically morecomplicated than batch systems.

Hemodialysis, APD (including tidal flow) and CFPD systems can employ apumping cassette. The pumping cassette typically includes a flexiblemembrane that is moved mechanically to push and pull dialysis fluid outof and into, respectively, the cassette. Certain known systems includeflexible sheeting on one side of the cassette, while others includesheeting on both sides of the cassette. Positive and/or negativepressure can be used to operate the pumping cassettes.

As described herein, the present disclosure provides a number ofimprovements to such fluid delivery systems.

SUMMARY

A first aspect of the embodiments described herein includes improvedproduct configurations. Here, different parts of the cassette-basedperitoneal dialysis system are configured advantageously, such as: (i)operational placement of the system; (ii) user interface configurationand orientation; (iii) disposable cassette loading; (iv) cassette/heaterand bag/tube management; (v) solution bag configuration; (vi) drain bagconfiguration; and (vii) storage and supply organization.

An second aspect of the embodiments described herein includes acapacitance electromagnetic compliance (“EMC”) seal for the display ofthe user interface of the dialysis system. The seal as seen below doesnot cover the viewable portion of the display, improving lighttransmittance and image quality versus known seals.

A third aspect of the embodiments described herein includes anelastomeric keypad for use with the display of the user interface of thedialysis system. The keypad, among other features, includes an ambientlight sensor that provides a signal output, which is used to controladjustment of display brightness and contrast based on a change inambient light.

A fourth aspect of the embodiments described herein includes a lowbattery disconnect circuit for the dialysis system. The circuit allowsthe battery back-up disconnect voltage to be set closer to the regulatedvoltage, enabling the dialysis system to operate longer on batteryback-up power.

A fifth aspect of the embodiments described herein includes an improvedsilent alarm for the dialysis system. The silent alarm system, amongother features, includes a transmitter that sends a signal to a remotealarming device, which can alert a caregiver to a dialysis systemfailure without disturbing the patent and/or people around the patent,who may be sleeping.

A sixth aspect of the embodiments described herein includes a visualsymbol or character shown on the display of the user interface of thedialysis system, which communicates pictorially ongoing happenings ofthe therapy, such as: (i) patient fill; (ii) solution dwell; (iii)patient drain; (iv) therapy status; (v) alarm status; (vi) patienthistory; (vii) therapy completed successfully; and (viii) system shutdown.

A first primary embodiment includes improved product configurations.Here, the cassette-based dialysis system can be configured to be placedon a patient's existing nightstand or be provided with its ownnightstand. The instrument or actuator unit of the system can beconfigured to accept the disposable cassette horizontally or vertically.The display and user interface of the actuator unit may be integral tothe actuator unit and for example be mounted at an upright angle or berotatable and closeable with respect to the remainder of the actuatorunit.

It is also contemplated to arrange the disposable cassette, heater bag,supply bag and tubing in a variety of advantages configurations. In oneimplementation the disposable cassette is integrated to the heater bag.In another implementation, the heater bag is coupled to ports extendingfrom the disposable cassette. The solution bags may be configured withany one or more of: (i) a spike seal that ensures a solution bag sealprior to pinching the solution bag; (ii) pre-attached tubing; and/or(iii) a delivery tray. The tubing may be configured with any one or moreof: (i) the supply tubes tacked together; (ii) a larger diameter drawhose; (iii) the patient and/or drain line coiled; (iv) the patientand/or drain lines pre-attached to the cassette; (v) leur connectionsprovided on the supply tubes for ready attachment to the supply bags;(vi) the patient tube pre-attached to the disposable cassette so as tobe in proper orientation for operation with a primary sensor; (vii)clamps color-coded and/or configured with line identification.

The drainage for the dialysis system may also be configuredadvantageously in a variety of ways. For example the drain tubes may beprovided with adhesive bonding and/or a clamp to help secure the drainbag and/or the drain bag. The drain bag may be configured: (i) with ahandle; (ii) to be reusable; (iii) to be a flexible bag or an at leastsemi-rigid container; (iv) to be a container with a handle oriented toeasily tip the container and/or with wheels; and (v) to be pre-attachedto the drain tube and/or the disposable cassette.

The organization of the dialysis system is also configurable in avariety of ways advantageously. One implementation includes anorganizational mat that prompts the patient to organize the fluidbags/containers properly and to gather the supplies needed. Anotherimplementation provides a solution bag tray that orients the solutionbags for optimum performance. Still a further implementation provides anightstand, which holds any one or more of: (i) the actuator unit; (ii)additional supplies; (iii) solution/drain bag; (vi) disposable cassette;and (v) tubing.

A second primary embodiment includes an improved display device, whichemploys a capacitance electromagnetic compliance (“EMC”) seal. Thedisplay device includes an insulating dielectric material (e.g., mylarfilm) placed between the metal case of the display device or monitor anda conductive coating located on the housing of the dialysis machine. Themetal case and metal coating are electrically isolated from each other.The dielectric material and the two conductive surfaces form a capacitorthat prevents leakage of electromagnetic energy.

In one implementation a medical machine includes: an enclosure definingan opening, at least a portion of the enclosure being electricallyconductive; an electrically operated component located inside theenclosure; a window placed adjacent to the opening; a conductive borderabutting the conductive portion of the enclosure; an insulating borderabutting the conductive border; and a video display including a casehaving an electrically conductive surface abutting the insulatingborder.

In one implementation, the electrically operated component includes atleast one apparatus selected from the group consisting of: a pump, aheater, a valve, a sensor, a pneumatic source, a disposable cassette, anactivator, and an occluder.

In one implementation, the window includes at least one characteristicselected from the group consisting of: (i) being at least substantiallyoptically transparent; (ii) being electrically insulative; (iii) beingat least substantially sealed to the enclosure; and (iv) being at leastsubstantially impact resistant.

In one implementation, the conductive border includes at least onecharacteristic selected for the group consisting of: (i) being aconductive film; (ii) being in contact with the conductive portion ofthe enclosure; (iii) being compressible; and (iv) being in contact witha ridge extending from the enclosure at least partially around the andoverlapping the window.

In one implementation, the enclosure includes at least onecharacteristic selected from the group consisting of: (i) the conductiveportion thereof including an electrically conductive coating applied tothe enclosure; (ii) being isolated electrically from the display; (iii)being sized to house components of a peritoneal dialysis machine; (iv)the opening thereof being shaped at least generally the same as thewindow; and (v) the conductive portion thereof contacting the conductiveborder to form a first capacitor plate, the conductive surface of thecase forming a second capacitor plate, the insulating border forming adielectric between the first and second capacitor plates.

In one implementation, the insulative border includes at least onecharacteristic selected from the group consisting of: (i) being made ofa dielectric material; (ii) being made of a plastic; (iii) being made ofmylar, (iv) being sized at least substantially the same as theconductive border; (v) being shaped at least substantially the same asthe conductive border; and (vi) being sandwiched between conductiveportions of the enclosure and the display to form a capacitor configuredto prevent leakage of electromagnetic energy from the enclosure.

In one implementation, the video display includes at least onecharacteristic selected from the group consisting of: (i) being a colordisplay; (ii) being a monochrome display; (iii) being operable with atouch screen; (iv) the at least partially conductive case forming afirst capacitor plate, the conductive border and conductive portion ofthe enclosure forming a second capacitor plate; and (v) having a portionconfigured to be in positive engagement with a force providing member sothat the display is pushed against the insulative border.

In one implementation, the medical machine is a dialysis machine.

In one implementation, a medical machine includes: an enclosure definingan opening, at least a portion of the enclosure being electricallyconductive and acting as a first capacitor plate; a medical devicecomponent located inside the enclosure; a window placed adjacent to theopening; a video display with an at least partially conductive caseacting as a second capacitor plate; and a dielectric member placedbetween the first and second capacitor plates, the plates and dielectricmember forming a capacitor for preventing leakage of electromagneticenergy from the enclosure.

In one implementation, the first and second capacitor plates contact thedielectric member.

In one implementation, the dielectric member forms a border having anopening enabling information displayed by the video display to be seenthrough the window.

In one implementation, the medical machine includes a conductive bordercontacting edges of the window and the conductive portion of theenclosure, the conductive border and the conductive portion of theenclosure acting as the first capacitor plate.

In one implementation, the medical machine includes at least onecharacteristic selected from the group consisting of: (i) the medicaldevice component including a fluid pump; (ii) the window being plastic;(iii) the conductive portion of the enclosure including a conductivemetal coating applied to the enclosure; (iv) the conductive portion ofthe enclosure being a conductive ridge; (v) the dielectric member beingmade of plastic; and (vi) the display configured to display at least oneof text and indicia relating to a therapy provided by the medicalmachine.

In one implementation, the medical device component located inside theenclosure is capable of generating electromagnetic energy (“EMI”), andthe capacitor is for preventing EMI from the medical device componentfrom leaking through the enclosure and EMI from outside the medicaldevice from leaking into the medical device.

A third primary embodiment includes an improved elastomeric keypad. Thekeypad, among other features, includes an ambient light sensor thatprovides a signal output that the dialysis system uses to adjust thebrightness and contrast of the display based on the amount of ambientlight sensed. The ambient light sensor is imbedded into or is otherwisesecured by the machine housing such that at least a portion of thesensor is oriented to be able to gather ambient light. The sensor isconnected with electronics to a backlight control function. The outputof the backlight control function controls the brightness of the userinterface display and keyboard backlighting. In one implementation, anincrease in ambient light results in a corresponding increase inbacklight intensity. Conversely, a decrease in ambient light results ina corresponding decrease in backlight intensity.

A fourth primary embodiment includes a low battery disconnect circuitfor use with the peritoneal dialysis machine. The cassette-based systemincludes a battery back-up power source. When the system is obtainingpower from the battery back-up, the output voltage of the batteryback-up gradually declines over time. The battery output is connected toa voltage regulator circuit that regulates the battery output to aconstant level. As the battery voltage declines, a point can be reachedin which the regulator can no longer hold the output voltage constant.The disconnect circuit serves to optimize this point to increase thelife of the battery back-up power source.

The regulator circuit includes a metal oxide field effect transistor(“MOSFET”). In the circuit, the MOSFET acts as a variable resistoraccording to its inherent on-resistance versus gate voltagecharacteristic. The regulator controller compares a feedback voltage atthe source of the MOSFET to an internal voltage reference and adjuststhe voltage at the gate of the MOSFET to produce a desired, regulatedoutput voltage. As the battery voltage declines, the regulatorcontroller increases the voltage at the gate of the MOSFET, whichaccording to the on-resistance versus gate voltage characteristicdecreases the drain to source resistance, reducing the voltage dropacross the MOSFET, so as to maintain the MOSFET source pin at a desiredregulated voltage. As described in detail below, the MOSFET regulatorcontroller and the remainder of the circuit enable the disconnection ofthe battery to be made at a voltage very close to the regulated voltage,maximizing battery back-up time. The circuit prolongs the use of thebattery back-up and enables more cost effective components to be used.

A fifth primary embodiment includes a silent or remote alarm apparatusthat operates with the cassette-based peritoneal dialysis system. Thesystem contains speakers that can be used to sound audible alarms at themachines. The system also includes a transmitter that can be usedalternatively to send a signal to a remote alerting device. The displayof the machine shows a visual message detailing the type of the alarmand/or instructions for addressing the alarm. A receiving unit receivesa signal sent by the transmitter and generates an audio, visual and/orphysical (e.g., vibrating) alarming output to the patient or to acaregiver or hospital member located remotely with respect to thepatient. The signal for example can be sent to a bed shaker that wakesonly the person that needs to be awakened, e.g., the patient orcaregiver. Family members or other patients in the room with the patientdo not have to be awakened needlessly.

In an sixth primary embodiment, the user interface displays a figure orcharacter that shows the progress of a number of treatment steps for thedialysis treatment. In the embodiments illustrated herein, the displayof the user interface displays a cartoon, video or other changeableimage of a drinking glass. The glass is filled during fill, dwell anddrain cycles. The filling of the glass in essence tracks the time orpercentage of completeness of the particular cycle. The glass includesindicia indicating whether the cycle is a fill, dwell or drain cycle.

The glass is non-imposing and provides a friendlier way to instruct thepatient during therapy. The glass is incorporated into other aspects ofperitoneal dialysis, such as alarm conditions, status reports, patienthistory, therapy completed successfully and system shut down.

It is therefore an advantage of the embodiments described herein is toprovide improved configurations for the components of a cassette-baseddialysis system.

Another advantage of the embodiments described herein to provideimprovements to the user interface of the dialysis system, such as animproved display, an improved keypad, an improved alarming capabilityand an improved state of therapy and therapy feature indication.

Yet a further advantage of the embodiments described herein is toprovide an improved battery back-up feature for a cassette-baseddialysis system.

Additional features and advantages of the embodiments described hereinare described in, and will be apparent from, the following DetailedDescription of the Disclosure and the figures.

BRIEF DESCRIPTION OF THE FIGURES

FIGS. 1A to 1F are perspective views illustrating different componentsof one configuration of a dialysis system employing the embodimentsdiscussed herein.

FIGS. 2A to 2F are perspective views illustrating different componentsof another configuration of a dialysis system employing the embodimentsdiscussed herein.

FIGS. 3A to 3E are perspective views illustrating different componentsof a further configuration of a dialysis system employing theembodiments discussed herein.

FIG. 4 is a perspective view illustrating one example of a userinterface for the dialysis system having a capacitance electromagneticcompliance (“EMC”) seal.

FIGS. 5 to 7 are schematic and elevation views showing one example of auser interface for a dialysis system employing the embodiments discussedherein.

FIGS. 8 and 9 are schematic views illustrating one example of a systememploying the embodiments discussed herein having a low batterydisconnect circuit.

FIG. 10 is a schematic view illustrating one example of a dialysissystem employing the embodiments discussed herein having a silent alarmcapability.

FIGS. 11A to 11D are machine screenshots illustrating an embodiment of agraphical depiction of a fill cycle of a dialysis system employing theembodiments discussed herein.

FIG. 12 is a machine screenshot illustrating an embodiment of agraphical depiction of a dwell cycle of a dialysis system employing theembodiments discussed herein.

FIGS. 13A to 13D are machine screenshots illustrating an embodiment of agraphical depiction of a drain cycle of a dialysis system employing theembodiments discussed herein.

FIG. 14 is a machine screenshot illustrating an embodiment of agraphical depiction offering treatment information for a dialysis systememploying the embodiments discussed herein.

FIG. 15 is a machine screenshot illustrating an embodiment of agraphical depiction offering alarm information for a dialysis systememploying the embodiments discussed herein.

FIG. 16 is a machine screenshot illustrating an embodiment of agraphical depiction offering patient information for a dialysis systememploying the embodiments discussed herein.

FIG. 17 is a machine screenshot illustrating an embodiment of agraphical depiction allowing the patient to change graphics/colorsettings in a dialysis system employing the embodiments discussedherein.

FIG. 18 is a machine screenshot illustrating an embodiment of agraphical depiction allowing the patient to change alarm settings in adialysis system employing the embodiments discussed herein.

FIG. 19 is a machine screenshot illustrating an embodiment of agraphical depiction allowing the patient to change alarm settings in adialysis system employing the embodiments discussed herein.

FIG. 20 is a machine screenshot illustrating an embodiment of agraphical depiction signifying that therapy has been successful for adialysis system employing the embodiments discussed herein.

FIG. 21 is a machine screenshot illustrating an embodiment of agraphical depiction signifying that the machine has gone into a standbymode for a dialysis system employing the embodiments discussed herein.

DETAILED DESCRIPTION

The embodiments described herein relate to medical fluid deliverysystems that employ a pump, such as a peristaltic pump. In particular,systems, methods and apparatuses for cassette-based dialysis therapiesincluding but not limited to hemodialysis, hemofiltration,hemodiafiltration, any type of continuous renal replacement therapy(“CRRT”), congestive heart failure treatment, CAPD, APD (including tidalmodalities) and CFPD are disclosed. The cassette is disposable andtypically discarded after a single use or therapy, reducing risksassociated with contamination.

Product Configurations

Referring now to FIGS. 1A to 1F a first configuration for the componentsof system 10 is illustrated by configuration 350. As discussed herein,in one embodiment the pumping technology used for system 10 is aperistaltic pump. It is expressly contemplated, however, that manyfeatures and embodiments discusses herein can be used with peristalticpumps, volumetric pumps, pumps operated pneumatically, pumps operatedmechanically, pumps operated hydraulically and any combination thereof.The component features discussed in connection configuration 350 andindeed in connection with configurations 370 and 390 shown in connectionwith FIGS. 2A to 2F and 3A to 3F, respectfully, are applicable to any ofthe different types of pumping technologies just previously described.Indeed, while cassette 50 is shown in connection with each ofconfiguration 350, 370 and 390.

As seen in FIG. 1A, configuration 350 of system 10 includes supply bags,14, 16, and 22 and drain bag 24. Those bags are connected fluidly tomachine or unit 60 via lines 28, 54, 20 and 32, respectfully, as seen inFIG. 1C additionally. FIG. 1A further illustrates that configuration 350of system 10 includes an organizational mat 352, which is shown anddiscussed in more detail in connection with FIG. 1F. FIG. 1A furtherillustrates that configuration 350 can be placed partly on a desk ornightstand, with drain bag 24 being placed on the floor. In theillustrated embodiment, supply bags 14, 16 and 22 and cassette 50 areloaded and maintained in an at least substantially horizontalconfiguration.

Referring now to FIG. 1B, machine or unit 60 is illustrated in moredetail. Here, unit 60 is a single integrated device, which includes ahorizontal front drawer 354, the back of which curves vertically, sothat a portion of cassette 50 is turned vertically for air separationpurposes. Cassette 50 and heater bag 356, shown in more detail inconnection with FIG. 1C, are loaded via drawer 354 simultaneously intounit 60. Drawer 354 also aids in organizing cassette 50 and heater bag356 to aid the patient in aligning, inserting and removing those items.To that end, the identification of the separate lines 28, 54, 20 and 32is also shown on drawer 354, so that the patient can match correspondingindicia on the lines with the markings on drawer 354 for proper cassetteinstallation. In the illustrated embodiment, display 66 of machine orunit 60 is tilted at an angle of about forty-five degrees to about sixtydegrees from vertical for ready viewing. Other angles could also beused. Unit 60 also includes controls 62 and 64, which can be off-screencontrols, such as membrane switches, or on-screen controls, such as atouch screen overlay.

Referring now to FIG. 1C, the disposable, sterile, fluid carryingportion of configuration 350 is illustrated. The disposable set includescassette 50 and separate heater bag 356, which are connected togethervia heater tubes. Thus, in configuration 350, heater 38 is locatedinside machine 60. As discussed above, unit 60 cooperates with drawer354 to turn a portion of heater bag 356 upwards for air separation. Inthe illustrated embodiment, heater bag 356 is loaded first via drawer354 into unit 60. The distill or free end of heater bag 356 is turnedupward. That end may contain a vent or a filter, such as a hydrophobicmembrane, which enables air escaping from the fluid in the heatingpathway to collect at the vertical upper end of heater bag 356 and toeventually be vented through such a vent or filter.

The disposable set includes a tubing organizer 358, which can be placedon the table or night stand to further assist the loading of cassette 50and heater bag 356. Organizer 358 holds supply lines 28, 54 and 20 nextto one another. Those lines in an embodiment are tacked or otherwiseheld together, so that the patient knows that those lines are intendedto be connected to supply bags 22, 16 and 14, respectively. Drain line32 in an embodiment has a larger diameter hose than do supply lines 28,54 and 20. This also helps the patient to keep the different linesstraight in memory. Thus it should be appreciated that in configuration350, cassette 50 and the lines connected to organizer 358 are loadedthrough the front of the unit 60, which places the tubes in anadvantageous viewing area in front of the patient.

The identification of supply lines 28, 54 and 20, drain line 32 andpatient line 12 is further aided via identifying markings. For example,clamps 360 (FIG. 1C) located at the distil ends of supply lines 20, 54,and 28 and drain line 32 are color-coded. Furthermore, the clamps canhave molded line identification or indicia. Patient line 12 isidentified via a connector 362 at its distil end. Connector 362 isremovably fixed to unit 60 as seen in FIG. 1A for priming. Unit 60 inone embodiment has a sensor, which senses whether connector 362 ofpatient line 12 is in proper position for priming before allowingtherapy to begin.

As seen in FIG. 1D, supply bags 14, 16 and 22 each include a port 364and a vent 366. Vent 366 for example includes a filter or a membrane,such as a hydrophobic membrane, which enables gas to be purged from thesupply bags. Ports 364 each include a seal, which is spiked via the endsof supply lines 28, 54 and 20. The seal eliminates the need for a clampon supply bag port 364.

Referring now to FIG. 1E, an embodiment for drain bag 24 is illustrated.Drain bag 24 also includes a port 364 and vent 366 as described above inconnection with FIG. 1D. Bag 24 also includes a handle 368 a, which aidsin carrying bag 24 when it is full of spent fluid. A handle 368 b isalso provided with machine 60 as seen in connection with FIG. 1B for itsready transport. As seen in FIG. 1E, drain line 32 is provided with oneor more apparatus, which enables the drain line to be fixed and held ina desired position. For example, drain line 32 can be provided with aflexible, adhesive-backed strip 372, which may enables the drain line tobe adhered to the desk or night stand, for example. Strip 372 in anembodiment slidably engages drain line 372 in frictional manner, so thatstrip 372 can be moved along drain line 32 to a desirable position.Additionally or alternatively, a clamp 374, which can be reusable, isprovided so that drain line 32 can be clamped in a desirable position.Clamp 374 slides over drain line 32 and in embodiment can be positionedfrictionally along different areas of the drain line.

As seen in FIG. 1F, organizational mat 352 includes indicia 376 a to 376e, which identifies the component at the illustrated location and wherea component, such as the supply bag and drain bag, should be located.Mat 352 is reusable and made of a washable material. The indicia canfurther include written instructions, reminders and other usefulinformation, such as color codes for the clamps and lines.

Referring now to FIGS. 2A to 2F, a second configuration 370 for system10 is illustrated. As before, configuration 370 is applicable to adialysis system employing any of the different types of pumpingtechnologies described herein. FIG. 2A shows configuration 370 usingdifferent shelves or levels of a desk, night stand, etc. Configuration370 is advantageous in one respect because supply bags may be tucked outof the way, leaving unit or machine 60 as the primary component that thepatient views. As seen additionally in FIG. 2F, configuration 370includes a bag stand 378, which orients supply bags 14, 16, and 22 in aposition which allows gravity to help fluid travel from the supply bagsto cassette 50. Stand 378 also organizes supply bags 14, 16 and 22 andincludes or defines a plurality of notches or openings that hold thetubing or connectors, which extend from the supply bags. Bag stand 378in one embodiment is made of vacuum-formed plastic or metal or isotherwise made of any suitable material.

FIGS. 2A and 2E illustrate that configuration 370 includes or uses areusable drain container 24, which in the illustrated embodimentincludes a rigid or semi-rigid housing 380. Housing 380 defines orincludes a handle 368 c. In the illustrated embodiment, housing 380 isattached to wheels 382 which further aid in the transporting of thehousing. FIG. 2E also shows that handle 368 c is positioned so thathousing 382 maybe tipped easily for drainage. To that end, an opening384 of container 24 positioned so as to be located at the bottom ofhousing 380 when it is tipped over. Housing 380 of reusable draincontainer 24 includes a reusable cap 386, which when tightened on tomating threads of housing 380 compresses a ferral or other type ofcompressible apparatus or seal, located at the end of line 32, into amating connector located or defined by housing 380.

FIG. 2B illustrates unit or machine 60 in more detail. As with unit 60of configuration 350, unit 60 of configuration 370 is a singleintegrated machine in the illustrated embodiment. Cassette 50 is loadedinto unit 60 horizontally as illustrated. Supply and drain tubes againenter device 60 from the front for easy access. Video monitor 66 ishinged so that it maybe adjusted to a suitable angle relative to a tableor nightstand on which it is placed, while closing to form a compact andportable unit. Rotatable monitor 66 operates in conjunction withcontrols 62 and 64, which again can be off-screen input devices (e.g.,membrane switches) or on-screen input devices that use a touch screenoverlay. Unit 60 can also have a handle (not illustrated) or be providedwith a bag or carrying case (not illustrated) for ready transport.

Referring now to FIG. 2C cassette 50 is shown loaded into unit 60.Cassette 50 includes an integrated fluid heating pathway 388. Integratedfluid heating pathway 388 can be a spiral path, which communicates withpathways located within the valve portion of cassette 50, such thatto-and from-heater ports are not needed. Fluid heating pathway 388operates with a heater 38 located within dialysis unit 60.

In the illustrated embodiment, patient line 12 and drain line 32 arepreattached to ports of cassette 50. Drain line 32 can again have alarger diameter than patient line 12 for reasons discussed above.Cassette 50 also has fluid connector or ports 392, which connect tosupply lines 20, 54, and 28. The supply lines or pigtails arepreattached to supply bags, 14, 16 and 22, respectfully.

As seen additionally in FIG. 2C, patient line connector 362 located atthe end of patient line 12 is pre-clipped or fastened to cassette 50 toorient the patient connector in proper position for priming. Further,drain line 32 and patient line 12 are coiled, so that cassette 50 can bemoved more easily. Clamps 360 located at the ends of drain line 32 andsupply lines 28, 54 and 20 can be color-coded as discussed above inconnection with configuration 350. In an embodiment, connectors locatedat the ends of supply lines 28, 54 and 20 match with colors of luerconnectors or ports 392 on cassette 50.

Referring now to FIGS. 3A to 3E, a third product configuration 390 isillustrated for system 10. Configuration 390 includes a dialysis machineor unit 60, having input devices 62 and 64 and a display device 66,including each of the alternative embodiments discussed above regardingthose components. As seen in FIGS. 3A and 3E, configuration 390 isprovided with an APD night stand 394. In FIG. 3E, a bottom draweropening 396 a receives a tray 398 a. Tray 398 a holds drain bag 24. Inthe illustrated embodiment, drain bag or container 24 is placed in atray 398 a, which is then slid into bottom opening 396 a. A middle tray398 b holds supply bags 14, 16 and 22 and cassette 50 in a middleopening 396 b. Tray 398 b is shown in more detail in connection withFIG. 3D. Top drawer 398 c located in top opening 396 c can be used forextra supplies for example. Drain container 24 can be pre-attached tocassette 50 or reusable as discussed above.

As seen in FIGS. 3C and 3D, the disposal portion of configuration 390 inone embodiment is integrated, so that the patient does not have toconnect any solution bag lines 20, 28 and 54. Also, patient line 12 anddrain line 32 are pre-attached to cassette 50. Here, patient setupmerely requires the patient to place patient line connector 362 locatedat the end of patient line 12 on a hook or other attachment device 402provided on the housing of unit 60 for prime. The patient connects drainline 32 to drain bag or container 24 and places container 24 in lowertray 398 a. As seen in FIG. 3D, solution bags 14, 16 and 22, which arepreattached to cassette 50 are loaded together as packaged in tray 398b. Here, the patient pulls cassette 50 from tray 398 b and places itinto a vertical slot 404 defined by machine 60. Thus in configuration390, cassette 50 is monitored vertically, which can be advantageous froman air separation stand point. Tubing connected to cassette 50 entersunit 60 via the side of cassette 50 in the illustrated embodiment.Cassette 50 includes an integrated fluid heating pathway 386, similar toor the same as that for configuration 370. Drain line 32 can also have alarger diameter than the supply and patient lines.

Display with Electromagnetic Compliance (“EMC”) Seal

Referring now to FIG. 4, one embodiment of a display usable with any ofthe machines or units 60 (e.g., FIGS. 1B, 2B and 3B) described herein isillustrated by machine display 400. Display 400 includes a video displaydevice 406. Video display device 406 is the component of machine display400 that generates the various images, e.g., color or monochrome, seenby the patient. The metal case of video display device 406 makesintimate contact with an insulating dielectric film 408, which in turnmakes intimate contact with an electrically conductive foam 410. Onesuitable display device 406 is provided for example, by SharpElectronics, Color Thin Film Transistor (“TFT”) Liquid Crystal Display(“LCD”), model LQ057. Suitable materials for insulative dielectric film408 include polyester, polycarbonate and mylar. The material can have athickness of about 0.003 inch (0.075 mm). One suitable material forelectrically conductive foam 410 is made by Schlegel or Insul-Fab,IFT-CF2-3030FR.

In an embodiment, conductive foam 410 is pressed against conductivecoated ridge 412, which is built into or formed with the non-conductivemachine casing 414. Ridge 412 extends around the perimeter of opening416 defined by machine casing 414, positions window 418 within casing414 and creates a surface for the conductive coating of ridge 412 tocontact conductive foam 410. Electrically conductive foam 410 has alarger outer dimension than does transparent window 418, which in anembodiment is an optically transparent, impact resistant, plastic piece.Accordingly, the outer edges of conductive foam 410 extend beyond window418 and thereby contact metal ridge 412. Insulating dielectric 408 isthe same size or wider in the inner and outer dimensions than isconductive foam 410. Therefore, insulating dielectric 408 preventsconductive foam 410 from contacting the metal case of display device406. Insulating dielectric 408 thereby provides an electricallyisolating barrier between conductive foam 410 and metal display 406.

Conductive foam 410 contacts ridge 412 of machine casing 414establishing an electrical connection. In this configuration, theconductive surfaces 410/412, the metal casing of display device 406 andthe insulating dielectric material 408 sandwiched between thoseconductive surfaces form a capacitive electromagnetic compliance (“EMC”)seal. A pressure sensitive adhesive (“PSA”) 420 forms an environmentalseal between transparent plastic window 418 and machine casing 414. Thatis, PSA 420 prevents dust and dirt from entering the inside of machinedisplay 400 via opening 416. A mounting bracket (not shown) is fixed tomachine casing 414, for example, via threaded couplers 422 welded to,heat staked or otherwise formed with machine casing 414. The bracketholds display device 406 and also compresses conductive foam 410 againstdisplay device 406 and ridge 412 of machine casing 414 to ensure goodelectrical contact between conductive foam 410 and the conductive coatedridge 412 of machine casing 414.

Machine display 400 takes advantage of the metal ridge 412 of casing414, which surrounds window 418, and the metal casing of display device406. The resulting EMC seal prevents electromagnetic energy (“EMI”)generated by the electronics within machine casing 414 from exiting orpassing through the casing 414 or display device 406. The EMC seal alsoprevents EMI generated by outside electronic devices from entering themachine through the paths just described. The above-described apparatuseliminates the need for shielding the entire display opening with anelectrically conductive window, which adds expense and can alsoadversely effect image quality. Machine display 400 eliminates the needfor an electrically conductive window altogether and thus eliminates thedisadvantages just described.

Display with Elastomeric Keypad

Referring now to FIG. 5, one embodiment for a user interface operablewith any of the machines 60 of system 10 (e.g., FIGS. 1A, 2A and 3A) isillustrated schematically by user interface 430. User interface 430includes an ambient light sensor 432, and interface circuit 434, controlelectronics/control function 436, a manual brightness button or othertype of manual input 438, a display backlight 440 and a keypad backlight442. Any one or more of the above-listed components can be provided on aprinted circuit board (“PCB”) located within dialysis machine 60. In analternative embodiment, interface circuit 434 is provided with sensor432, located separately from the PCB.

Ambient light sensor 432 senses an amount of ambient light in the roomin which machine 60 is positioned and sends a signal such as a zero toten volt or 4 to 20 milliamp variable output signal to the interfacecircuitry 434. Interface circuit 434 conditions the signal from theambient light sensor to make it readable or useful to the controlelectronics/control function 436.

The user interface backlight electronics 436 also receives a variableinput signal from manual brightness input or rotary knob 438. Asdescribed below in detail, input or knob 438 in one embodiment sets aninitial brightness setting desired by the patient or operation. In analternative embodiment, the signal from the manual brightness input 438overrides the automatic backlighting provided via ambient sensor 432,interface circuit 434 and backlight electronics 436. As seen in FIG. 6,rotary knob operates with directional arrows 446.

Whether user interface backlight electronics 436 is controlled viasensor 432 and interface 434 or via a signal from manual controller 438,the user interface backlight control function 436 outputs a variableamount of power to backlight display 440 and keypad backlight 442. Thepower to display backlight 440 can be the same as the power to keypadbacklight 442, or the power to one of the backlights can be different,e.g., scaled by a factor, of the power to the other backlight. Forexample, the keypad backlight may be controlled automatically to beslightly less bright than the display backlight 440 set initially viainput 438 or vice versa. In an alternative embodiment, display backlight440 can be controlled independently from keypad backlight 442. Forexample, although not illustrated, a second manual brightness controlbutton, knob or controller can be provided, so that there is separatemanual control of display backlight 440 and keypad backlight 442. Theuser or patient may want to set the display backlight to be morebrightly lit, while the keypad backlight is set to be more dim or viceversa. Separate controls would also allow the user to turn one of thebacklights off, while keeping the other on if desired.

It is expected that machine 60 (e.g., FIGS. 1B, 2B and 3B) will beoperated in a varying ambient light environment because the machine maybe used to perform dialysis at home and at any time during the day ornight. For example, the machine may be set up at night under normal roomlight conditions and perform therapy thereafter while a person sleepswith the lights off. Machine 60 at any time during therapy may need towarn the patient of an error or alarm and wake the patient potentiallyin a dark or dimly lit room. User interface 430 including automaticallyvariable lighting automatically adjusts backlight intensity tocompensate for changes in ambient light level so that such errors oralarms may be seen easily.

FIG. 6 shows machine 60 operating with variable ambient light userinterface 430. Ambient light sensor 432 is positioned to receive lightimpinging on machine 60. Light sensor 432 in an embodiment includes aphoto receptor having a spectral response approximately that of thehuman eye, such as an LX1970 Visible Light Sensor provided by MicrosemiCorporation, Garden Grove, Calif. This sensor includes processing thatprovides a photopic light wavelength response curve that nearlyduplicates that of the human eye. Control function 436 shown in FIG. 5sets the backlight brightness 440 and 442 to the level set by the userand modifies the backlight in response to changing ambient light levels.For example, control function 436 can be configured so that an increasein ambient results in a corresponding increase in backlight intensity440 and 442. Conversely, a decrease in ambient light results in acorresponding decrease in backlight intensity 440 and 442. Backlightcontrol function 436 also compensates for any non-linearity of ambientlight sensing. Backlight control function/electronics 436 can be adedicated analog circuit, a dedicated digital circuit (such as amicrocontroller), hybrid of both or be a functional element of ashared-embedded application processor. The function may also beimplemented on an application specific integrated circuit (“ASIC”).

As discussed above, the patient adjusts the ambient light setting viaadjustment device 438, which includes a dial or knob for example. Device438 controls a variable electrical output signal to backlight controlfunction 436. Function 436 can be set to time-out after a period ofnon-adjustment, following a period of adjustment or control 436 to knowwhen the desired setting has been made. Thus after the patient changesthe desired amount of light, circuitry 434 waits a period of time afterthe change to know that the change has been set. After this amount oftime, control function/electronics 436 is set to assume that the desiredbacklight setting has been made.

The setting can be made in any ambient condition. Controlfunction/electronics 436 is configured to modify its output if theambient conditions change, so that the overall backlight brightnesslevel stays at the level set by the user. For example, if the patientsets a desired level during normal lighting conditions to a high backlitlevel and then night falls or the patient turns out room lights,electronics 436 would decrease the power to backlights 440 and 442 andmaintain the relative brightness between the backlights 440 and 442 andthe ambient light. In this embodiment, a fixed level is adjustable afterwhich circuitry 434 adjusts the backlight 440 and 442 to achieve ormaintain that setting made by the patient. In another embodiment, manualcontrol or rotary knob 438 overrides an automatic, e.g., optimizedsetting made in software in which power is adjusted based on ambientlight compared to the automatic setting.

In an alternative embodiment, control function 436 is configured tocompensate for the human eye's change in sensitivity due to ambientlight levels integrated over time. As is known, the longer a personresides in the dark, the more sensitive the person's eye becomes. Thisphenomenon is sometimes termed as “dark adaptation” or “unaided nightvision.” In this alternative embodiment, control function 436 wouldgradually reduce power to one or both of display backlight 440 andkeypad backlight 442 over time and over a steady ambient light readingvia sensor 432. This feature in an embodiment is performed only whencontrol function 436 determines that it is dark enough to do so, such asat a particular ambient light, read from sensor 442, or lower.

In FIG. 6, user interface 430 includes buttons that are visible to theuser, such as buttons 62 a to 62 d. User interface 430 also includes“hidden” buttons or inputs 64 a and 64 b. In an embodiment, visiblebuttons 62 a to 62 d are three dimensional and raised to allow thepatient to have enhanced finger traction and feel and for ease inlocating a desired function. Buttons 62 a to 62 d provide tactilefeedback when pressed. Each visible button 62 a to 62 d includes a threedimensional icon or indicia, which can be raised or inset so that avisually impaired person can identify a particular button through touchalone. Visible buttons 62 a to 62 d in an embodiment are color-coded orotherwise unique visually and/or tactily to further aid in theiridentification. As seen in FIG. 7, each visible button 62 a to 62 d isbacklit individually, wherein control function 436 of FIG. 5 can beconfigured to light only buttons which are currently operational.

Hidden buttons 64 a and 64 b are provided behind front panel 428. Inputs64 a and 64 b are accordingly shown in phantom. Front panel 428,however, may include indicia 444 that mark the areas of hidden buttons64 a and 64 b. The patient presses icons 444 displayed on front panel428 to activate hidden buttons 64 a and 64 b. Hidden buttons 64 a and 64b can also provide tactile feedback through front panel 428 to informthe patient that the hidden button is being activated. Further, thepatient can view changes occurring on video monitor 66 to receive suchfeedback and recognition. Hidden buttons 64 a and 64 b are advantageousfor certain applications, including but not limited to nurse mode orservice mode buttons or other buttons that are not used typically by thepatient but used instead by clinicians or service personnel.

Although four visible buttons 62 and two hidden buttons 64 areillustrated, user interface 430 can have any suitable number of visibleand hidden buttons, which can be push type buttons, rotary knobs, suchas rotary knob 438, toggle switches, maintained or momentary buttons,sliding input devices, and any suitable combination thereof.

As discussed throughout this application, electromechanical buttons 62(referring collectively to button 62 a to 62 d) and hidden buttons 64(referring collectively to buttons 64 a and 64 b) can instead beprovided on a touch screen overlay, which operates with video screen 66.It is advantageous to use the electromechanical configuration in onerespect because the electromechanical buttons allow for the buttons tobe three-dimensional, which enhances tactile feedback and recognition.

Referring now to FIG. 7, a light emitting diode (“LED”) board 426 isillustrated. LED board 426 shows different patterns for keypadbacklighting 442 (442 a to 442 f) discussed above in connection withFIG. 5. In particular, LED board 426 includes backlight pattern 442 aoperable with visible button 62 a (FIG. 6), backlight pattern 442 boperable with visible button 62 b (FIG. 6), backlight pattern 442 coperable with visible button 62 c (FIG. 6), backlight pattern 442 doperable with rotary knob 438 (FIG. 6), backlight pattern 442 e operablewith directional arrows 446 (FIG. 6), and keyboard backlight pattern 442f operable with visible button 62 d (FIG. 6). Patterns 442 a to 442 fare arranged as desired to provide a desired amount and spacing ofbacklighting behind buttons 62 (62 a to 62 d) and control knob 438. Asdiscussed previously, LED arrangements 442 a to 442 f can be litindividually, so that only active buttons are lit for example. This canhelp in machine setup and operation to guide the patient throughdifferent screens of therapy.

Low Battery Disconnect Circuit

Referring now to FIGS. 8 and 9, circuit 470 illustrates one embodimentof a low battery disconnect circuit used with the electronics and userinterface of system 10. Circuit 470 is located within control unit 60(e.g., FIGS. 1B, 2B and 3B) and in an embodiment is provided on aprinted circuit board, such as a delegate circuit board, whichcommunicates with a supervisory PCB. Circuit 470 provides back-up powerto machine 60 in an event that the main power source is interrupted.When the back-up power is used its output voltage level graduallydeclines over time as is known. The electronics driven by the batteryback-up however need a steady voltage to operate reliably. A voltageregulator can be used to regulate the voltage at a steady level. Asbattery voltage declines, the regulator reaches a point that it cannothold the voltage output steady based on the voltage it sees from thebattery. If the duration of the main power source interruption continueslong enough, the battery discharge continues to the point that loss ofregulation occurs. When this happens the machine must be shutdown. Thisresult should be avoided to ensure reliable machine operation. Circuit470 enables the disconnect point to be safely near the point of loss ofvoltage regulation. Accordingly, circuit 470 lengthens the amount oftime that machine 60 can run on battery back-up.

Circuit 470 includes a battery 472, a metal oxide semiconductor fieldeffect transistor (“MOSFET”) 474, a voltage regulator 476, a voltagecomparator 478, which receives a reference voltage 480, a regulatedvoltage output 482 and system ground 484. A negative terminal of battery472, the voltage regulator 476 and the regulated voltage output 482 areall referenced to system ground 484.

Voltage regulator 476 receives a disable input 486 a from voltagecomparator 478 and a feedback input 486 b from the source 488 of MOSFET474. Regulator 476 also provides a voltage output 494 to the gate 490 ofMOSFET 474 as well as to a positive terminal of voltage comparator 478.One suitable voltage regulator 476 is provided by Micrel SemiconductorInc, San Jose, Calif., part # MIC 5158, which is used in combinationwith a latch (not illustrated) that latches the disabled state. Thepositive terminal of battery 472 is connected electrically to the drain492 of MOSFET 474.

Circuit 470 takes advantage of an inherent characteristic MOSFET 474,which is an on-resistance versus gate voltage characteristic. FIG. 9illustrates this characteristic. The characteristic is as follows. Asdiscussed, the voltage of battery 472 needs to be higher than theregulated output 494 of voltage regulator 476 to provide a linearregulator typology. For example, the starting voltage of battery 472 canbe six VDC, while the regulated output 494 is five VDC. The initialfully charged battery 472 can actually have a voltage of 6.1 VDC, forexample. A voltage reference 480 supplied to the negative terminal ofvoltage comparator 478 in this example could be five VDC. Regulator 494compares feedback voltage 486 b to the voltage reference and adjusts itsoutput 494 to gate 490 of MOSFET 474 so that the regulated output 482 isfive VDC.

When drain 492 of MOSFET 474 for example sees an initial voltage 6.1 VDCfrom battery 472 and source 488 is set to five VDC, a voltage drop(“VDS”) of 1.5 VDC occurs across MOSFET 474. As voltage of battery 472declines, regulator 476 increases its output 494 at gate 490 of MOSFET474, which decreases the drain to source on-resistance as seen in FIG.10, and which therefore reduces the voltage drop across MOSFET 474 tomaintain the voltage at MOSFET source 488 to be 5 VDC.

In circuit 470, MOSFET 474 therefore acts like a variable resistor. Iffor example the load being driven by regulated output 482 is drawing 1Amp and batter 472 has already been drained to the point at which itsvoltage is 5.1 VDC, the drain-to-source voltage (“VGS”) is 0.1 VDC andthe drain-to-source resistance is 0.1 Ohms (0.1 VDC÷1 Amp=0.1 Ohm). WhenRDS is at 0.1 Ohm as seen in FIG. 10, VGS is about three VDC. As batteryvoltage continues to decline, the operating point of MOSFET 474 movesdown along the curve of FIG. 9. Here, regulator 476 continues toincrease VGS, while the resistance of MOSFET 474 continues to decreasein compensation.

As seen in FIG. 9, when RDS drops to about 0.03 Ohm, the curve begins toflatten considerably, so that VGS has to increase more and moredramatically to effect the same change in RDS. When VGS reaches 12 VDC,the curve is almost completely horizontal, meaning MOSFET 474 is almostfully on and RDS is about 0.022 Ohm. Here the threshold of comparator478 is finally reached or surpassed when VGS becomes more positive thanthe threshold voltage. When VGS reaches this 12 VDC threshold in theexample, comparator 478 switches and regulator 494 becomes disabled,driving VGS to zero, disconnecting battery 472 from the load connectedto regulated output 482 effectively.

In one embodiment, the minimum achievable RDS for MOSFET 474 is about0.02 Ohm. Regulator 476 is chosen such that it can drive VGS to at least15 VDC, so that RDS can reach 0.02 Ohm according to FIG. 10. If it isassumed again that the load driven by regulated output voltage 482 isone Amp, then for example VDS is 0.02 VDC at the minimum RDS of MOSFET474 of 0.02 Ohm. In the example, the lowest voltage that battery 472could provide to yield a regulated output voltage at 482 would thereforebe 5.02 VDC. Reference voltage 480 for comparator 478 is set in oneembodiment to 12 VDC. As discussed above, this yields an on-resistanceof 0.022 Ohms, which in the one Amp example occurs when battery voltagedrops to 5.022 VDC. Thus, the theoretical minimum for battery 472 is5.02 VDC, while the actual sustainable voltage minimum for battery 472is 5.022 VDC. This results in a mere loss of 2 millivolts above thetheoretical limit.

Circuit 470 accordingly provides topology that allows for lowertolerances and therefore lower precision and thus lower cost parts to beused in a safe and reliable circuit. It should be appreciated that evenif the actual to theoretical low voltage output varies by plus or minus25%, the resulting disconnect threshold varies by less than 5millivolts. It should also be appreciated therefore that circuit 470eliminates the need for a precision comparator function and safetymargin, which has been used in the past to ensure that the thresholddoes not drop below the level at which regulation can be maintained.Adding a safety margin means that the nominal threshold voltage is movedhigher, which results in a disconnected or battery voltage higher thanthat achievable with a topology of circuit 470. Disconnecting at ahigher voltage means less time available to operate on battery back-up.

In an alternative embodiment, the output of comparator 478 is used totrigger an interrupt to one or more processors of system 10, trigger adelay circuit (not illustrated) and have the output of the delay circuittrigger the shutdown of system 10. This approach signals to the one ormore processor that power is to be disconnected shortly, giving theprocessor an opportunity to prepare for shutdown of system 10. Forexample, the system could send an alarm to the patient, close one ormore valve, ramp down one or more pump and record the status of therapy(such as the amount of fluid pumped per current cycle, amount ofultrafiltrate removed, etc.) and perform any other safety measure neededto prepare for shutdown.

It is also contemplated to use circuit 470 or the alternative interruptcircuit to notify a processor whenever a switch to battery back-upoccurs, wherein the processor has the further capability to shut offpower. In such case, circuit 470 or the alternative interrupt circuitcan provide a back-up shut-off circuit in case the processor fails toshut itself off.

In a further alternative embodiment, a second comparator is providedhaving a voltage threshold less than that of comparator 478. The lowerthreshold voltage second comparator generates a processor interruptsignal when VGS becomes more positive than the threshold voltage. Thehigher threshold voltage of comparator 478 causes the system to be shutdown when VGS becomes more positive than the higher threshold voltage.This causes a time delay.

Silent Alarm Capability/Remote Alerting

Referring now to FIG. 10, one embodiment of system 10 having a silentalarm capability is illustrated. As discussed above, it is desirable incertain circumstances not to have machine or unit 60 of system 10 (e.g.,FIGS. 1A, 2A and 3A) sound an alarm itself. For example, unit 60 mayhave to be located near other sleeping people who do not need to beawoken upon an alarm condition. In other instances, the patient and/orpatient's spouse can be hearing impaired or deaf and not be able torespond to an audible alarm from unit 60 of system 10. As discussedbelow, the silent alarm capability of system 10 solves these dilemmas.

FIG. 10 shows the machine 60, which is configured similar to that shownin connection with FIG. 3B. It should be appreciated, however, that thesilent alarm capability can be provided with any of the machines 60described herein for system 10. Machine 60 houses a transmitter 500. Onesuitable transmitter 500 is provided by Harris Corporation SC-DOT1003-1transmitter. Another suitable transmitter is an Alert Master Model 6000,part number AMER-AM 6000. In an embodiment, transmitter 500 ismicroprocessor controlled. The microprocessor in an embodiment isprovided on a safety controller or safety PCB, which operates with asupervisory microprocessor. The integration of transmitter 500 andmicroprocessor control helps to prevent false alarms because themicroprocessor decides when transmitter 500 should send signal 502.

Transmitter 500 transmits a radio frequency (“RF”), microwave,ultrasonic or infrared signal 502, which can be received by one or moreremote receiver. For example, the remote receiver can be a remote alarm,headset or computer 504, which generates a visual or audible alarm in aplace located remotely from machine 60. Alarm 504 alerts a caregiver orrelative that machine 60 of system 10 is experiencing an alarmcondition. Video monitor 66 of machine 60 posts an alarm message 506,which can (i) describe the nature of the alarm and/or (ii) provide asuggested course of corrected action. Signal 502 can be continuous,e.g., for three seconds, or pulsed as desired.

In an alternative embodiment, transmitter 500, as provided by HarrisCorporation CC-PS1001, Private Page, is a local wireless paging systemthat sends its signal 502 to a remote pager or cellphone 508. Pager orcellphone 508 is worn by a caregiver or relative. The pager responds tosignal 502 in a known manner, alerting the caregiver or relative toproceed to machine 60 and observe visual message 506.

In still a further alternative embodiment, transmitter 500 sends signal502 to a bed shaker 510. One suitable bed shaker is provided by HarrisCommunications Super-Shaker Model SA-SS120V, 120VAC. DC Model isSA-SS12V. Bed shaker 510 is placed beneath the patient or is otherwisecoupled to the patient's bed, so that the patient is awakened upon analarm. This can be done so as not to wake other people nearby.

In further alternative embodiments, signal 502 can be sent to anycombination of remote alarm 504, pager 508 and/or bed shaker 510.Further, machine 60 can be configured with one or more speakers 512.Speakers 512 provide an audible alarm at machine 60, which can be madein lieu of or in addition to the signaling of the remote devices.Speakers 512 can alternatively provide an audible version of message506, which audibly tells the patient, caregiver or relative what to doto correct the current alarm condition. For example, signal 502 can besent to remote alarm 504 or pager 508, alerting a person to come tomachine 60, at which point the person hears an audible message fromspeaker 512 informing the person of the nature of the alarm and likelycorrective action.

In any of the previously mentioned embodiments involving transmitter500, the transmitter 500 exist alternatively externally to machine 60and its display 66. This is done via an external interface connectionthrough machine 60. The interface of machine 60 provides a polar/binarysignal, ON/OFF signal or data stream interface, such as serial orparallel interface, depending upon the type of remote transmitter 500used.

Graphical Display of Progress Dialysis Treatment Steps

Referring now to FIGS. 11A to 11G, screen shots of video monitor 66 ofdialysis machine 60 of system 10 (e.g., FIGS. 1A, 2A and 3A) illustratea fill cycle, such as a PD fill cycle graphically via a character 520.As shown here and in subsequent figures, character 520 is usedthroughout the therapy, to provide the patient with a consistent andfamiliar treatment display.

In the illustrated embodiment, a character 520 is shown as an animateddrinking glass. It should be appreciated, however, that character 520can have other suitable forms, shapes and/or indicia. In one embodiment,different characters or shape of a same character are provided aschoices to the patient in a set-up mode. The character or shape chosenis used thereafter throughout the screens to display therapy progressand other information discussed below. The patient can change thecharacter or shape at any time or in between treatments.

In a preferred embodiment, character 520 has a friendly appearance,which also aids in relieving the stress of treatment. Character 520 addsa human element to therapy and provides useful information to thepatient. It is contemplated that when such information is presented in auser-friendly format, the patient has a better probability of receivingand understanding the information.

In the fill cycle of FIGS. 11A to 11D, glass 520 is shown initiallyempty in FIG. 11A and is filled incrementally in FIGS. 11B and 11C,before being filled completely in FIG. 11D, indicating that the fillcycle is complete. Character 520 includes or has a therapy indicator522, which in the illustrated embodiment is a hand extending from thebody of glass 520, which points to or otherwise indicates which cycle ofthe therapy is currently underway. An up arrow 524 a is providedinitially to illustrate that the level of dialysis fluid is increasing,i.e., that a fill cycle is occurring. The water level in glass 520 onthe other hand indicates a stage of a particular cycle. A fuller glassindicates that a later portion of the current cycle is taking place. Theindicia of character 520, e.g., the face shown on the glass, is alsoconsistent with the fact that system 10 is currently in an active, e.g.,fill mode.

Referring now to FIG. 12, a screen shot of video monitor 66 illustratesa dwell cycle, which occurs after the patient's peritoneum has beenfilled with a fill volume of dialysate. The dwell cycle is a relativelyinactive cycle for system 10. Machine 60 is not pumping liquid to orfrom the patient. Thus, indicia 526 illustrates that the glass appearsto be resting or sleeping. Up arrows 524 a (FIGS. 11A to 11D) arereplaced by circular or dwell arrow 524 b. Dwell arrow 524 b indicatesthat the volume of fluid within the patient's peritoneum is currentlynot changing but is instead circulating or moving within the patient toremove waste and toxins. Glass 520 remains full of fluid during thisperiod because the patient's peritoneum also remains full of fluid.

Referring now to FIGS. 13A to 13D, character 520 animates a drain cycle.Animations for any of the cycles can be cartoon animations, video clipsand any combination thereof. Here, glass 520 is drained progressively inFIGS. 13A to 13D to indicate that drain is taking place and how much ofthe drain cycle has occurred. Glass 520 is full at the beginning of thedrain cycle in FIG. 13A. At the end of the drain cycle in FIG. 13D,glass 520 is emptied completely, indicating the end of the drain cycle.Character indicator 522 and down arrow 524 c both point downward,indicating fluid is leaving the patient, that is, indicating thatmachine 60 is currently in a drain cycle.

Any of the fill, dwell and drain cycle sequences can be accompanied byan elapsed time display, a time remaining display, an indication ofwhether the cycle, e.g., drain cycle is a first drain cycle, a seconddrain cycle, for example. The face of glass 520 also indicates that theglass is awake, e.g., that machine 60 of system 10 is in an activepumping cycle.

In an embodiment, the filling of glass 520 in any cycle occurscontinuously, that is, the fill level is moving continuously albeitslowly during a particular cycle. In another embodiment, the levelchanges after an increment of time, e.g., every ten seconds, everythirty seconds, every minute, every five minutes, etc. Or, the levelchanges after an increment of volume, e.g., after every 10 millimeterspumped, 30 millimeters pumped, etc. The filling of glass 520 is alsotied to other events that occur during treatment that may stop thefilling. For example, if an alarm condition occurs in which pumping isstopped, video monitor 66 is configured to stop the display of thefilling of glass 520.

Referring now to FIGS. 14 to 16, video monitor 66 is further configuredto display other aspects of therapy, such as PD. As seen in FIGS. 14 and16, character 520 is used in certain of these additional displays, whileFIG. 15 illustrates that character 520 does not have to be displayed ineach screen shot or for each feature of system 10.

FIG. 14 illustrates a therapy report or therapy tracking screen in whichcharacter 520 holds a report 528 indicating that particular parametersof a previous treatment or therapy have been recorded. In an embodiment,video monitor 66 operates with a touch screen overlay, in which case thepatient can press therapy report 528 to review treatment information.Treatment information can include any potentially desirable information,such as, treatment time, volume delivered, fill times, dwell times,drain times, number of cycles, UF removed, average dialysatetemperature, alarm information, etc. In an alternative embodiment,electromechanical inputs, such as visible buttons 62 or hidden button 64are used to recall information indicated by therapy report 528.

FIG. 15 illustrates an alarm screen, which includes an alarm indicator530 and an alarm report 532. In an embodiment, the screen of FIG. 15 isdisplayed upon an alarm condition. If video monitor 66 operates with atouch screen overlay, either one or both of alarm indicator 530 andalarm report 532 can be touched to cause visual, audio or audiovisualalarm information to be given to the patient. In an alternativeembodiment, the screen of FIG. 15 is shown at the end of treatment sothat the patient can review a separate alarm report 532 to learn of anyalarm conditions that occurred during the previous therapy or to learnof any alarms that have occurred over recent therapies, such as over thelast week or month.

In FIG. 16, video monitor 66 shows a patient information screen. Here,character 520 is shown in combination with a file or folder 534, whichrepresents a patient file or patient history. Here again, if videomonitor operates with a touch screen overlay, file 534 can itself beselected to show patient history, treatment parameters, backgroundinformation and any other desirable patient-specific information.Otherwise, electromechanical inputs are used.

In an embodiment, the screens of FIGS. 14 to 16 are sub-screens obtainedselectively via a main screen or supervisory sub-screen. Sub-screenselection can be done via a touch screen input or via electromechanicalinput, such as a scrolling input device that enables the patient toscroll through the icons representing the different screens (e.g.,characters 520 in different settings) before selecting one of the iconsto display the selected screen.

Referring now to FIGS. 17 to 19, different screen shots of video monitor66 show different icons in combination with an up and down arrow 536.Up/down arrow 536 indicates that corresponding settings can be changedfor a particular function indicated by its associated icon 520, 530 or538. FIG. 17 for example shows glass 520, which if pressed allows theuser to change characters, e.g., from a glass to a person, color of thecharacter, e.g., blue to red, or shape of the character, e.g., glass asshown to a mug, for example. To these ends, any of the screens discussedherein can be associated with a touch screen overlay, which communicateswith a touch screen controller, which in turn communicates directly orindirectly with a supervisory processor, controller or printed circuitboard. Thus, glass 520 and arrow 536 can correspond to selectable areasor the touch screen. Alternatively, membrane switches or other types ofelectromechanical input devices are provided to enable the user tointeract with glass 520 and arrow 536.

FIG. 18 shows arrow 536 operable with alarm 530. This screen enables thepatient to change (as indicated by up and down arrow 536) the alarmsettings. Alarm 530 can be colored yellow or red or otherwise brightlyto indicate that the function is significant or to caution or warn thepatient of a particular condition. FIG. 19 shows arrow 536 operable witha control panel 538. This screen allows the operator to changeinstrument settings, such as, volume settings, brightness settings andother user preferences relating to the operation of the dialysismachine.

Referring now to FIGS. 20 and 21, video monitor 66 illustrates character520 at the end of therapy or cycle. FIG. 20 illustrates a therapysuccessfully completed screen. Here character 520 and characterindicator 522 indicate that the previous treatment or treatment cyclehas been completed successfully. FIG. 21 shows character 520 in a restor sleep mode. Here, character 520 is indicating that the machine, whilepowered, is in a shut-down or dormant mode, in which therapy has endedor is in a paused or waiting state for a task to be completed or commandto be entered.

Character 520 is shown above displaying parameters for a PD system. Inan alternative embodiment, character 520 is used in a blood filteringdialysis therapy, such as, HD, HF or HDF. Here, character 520 canindicate ultrafiltration and the percentage of a prescribed amount ofultrafiltrate that has been removed at a certain point during treatment.

It should be understood that various changes and modifications to thepresently preferred embodiments described herein will be apparent tothose skilled in the art. Such changes and modifications can be madewithout departing from the spirit and scope of the present disclosureand without diminishing its intended advantages. It is thereforeintended that such changes and modifications be covered by the appendedclaims.

1. A medical machine comprising: an enclosure defining an opening, atleast a portion of the enclosure being electrically conductive; anelectrically operated component located inside the enclosure; a windowplaced adjacent to the opening; a conductive border abutting theconductive portion of the enclosure; an insulating border abutting theconductive border; and a video display including a case having anelectrically conductive surface abutting the insulating border.
 2. Themedical machine of claim 1, wherein the electrically operated componentincludes at least one apparatus selected from the group consisting of: apump, a heater, a valve, a sensor, a pneumatic source, a disposablecassette, an activator, and an occluder.
 3. The medical machine of claim1, wherein the window includes at least one characteristic selected fromthe group consisting of: (i) being at least substantially opticallytransparent; (ii) being electrically insulative; (iii) being at leastsubstantially sealed to the enclosure; and (iv) being at leastsubstantially impact resistant.
 4. The medical machine of claim 1,wherein the conductive border includes at least one characteristicselected for the group consisting of: (i) being a conductive film; (ii)being in contact with the conductive portion of the enclosure; (iii)being compressible; and (iv) being in contact with a ridge extendingfrom the enclosure at least partially around the and overlapping thewindow.
 5. The medical machine of claim 1, wherein the enclosureincludes at least one characteristic selected from the group consistingof: (i) the conductive portion thereof including an electricallyconductive coating applied to the enclosure; (ii) being isolatedelectrically from the display; (iii) being sized to house components ofa peritoneal dialysis machine; (iv) the opening thereof being shaped atleast generally the same as the window; and (v) the conductive portionthereof contacting the conductive border to form a first capacitorplate, the conductive surface of the case forming a second capacitorplate, the insulating border forming a dielectric between the first andsecond capacitor plates.
 6. The medical machine of claim 1, wherein theinsulative border includes at least one characteristic selected from thegroup consisting of: (i) being made of a dielectric material; (ii) beingmade of a plastic; (iii) being made of mylar, (iv) being sized at leastsubstantially the same as the conductive border; (v) being shaped atleast substantially the same as the conductive border; and (vi) beingsandwiched between conductive portions of the enclosure and the displayto form a capacitor configured to prevent leakage of electromagneticenergy from the enclosure.
 7. The medical machine of claim 1, whereinthe video display includes at least one characteristic selected from thegroup consisting of: (i) being a color display; (ii) being a monochromedisplay; (iii) being operable with a touch screen; (iv) the at leastpartially conductive case forming a first capacitor plate, theconductive border and conductive portion of the enclosure forming asecond capacitor plate; and (v) having a portion configured to be inpositive engagement with a force providing member so that the display ispushed against the insulative border.
 8. The medical machine of claim 1,which is a dialysis machine.
 9. A medical machine comprising: anenclosure defining an opening, at least a portion of the enclosure beingelectrically conductive and acting as a first capacitor plate; a medicaldevice component located inside the enclosure; a window placed adjacentto the opening; a video display with an at least partially conductivecase acting as a second capacitor plate; and a dielectric member placedbetween the first and second capacitor plates, the plates and dielectricmember forming a capacitor for preventing leakage of electromagneticenergy from the enclosure.
 10. The medical machine of claim 9, where thefirst and second capacitor plates contact the dielectric member.
 11. Themedical machine of claim 9, wherein the dielectric member forms a borderhaving an opening enabling information displayed by the video display tobe seen through the window.
 12. The medical machine in claim 9, whichincludes a conductive border contacting edges of the window and theconductive portion of the enclosure, the conductive border and theconductive portion of the enclosure acting as the first capacitor plate.13. The medical machine of claim 9, which includes at least onecharacteristic selected from the group consisting of: (i) the medicaldevice component including a fluid pump; (ii) the window being plastic;(iii) the conductive portion of the enclosure including a conductivemetal coating applied to the enclosure; (iv) the conductive portion ofthe enclosure being a conductive ridge; (v) the dielectric member beingmade of plastic; and (vi) the display configured to display at least oneof text and indicia relating to a therapy provided by the medicalmachine.
 14. The medical machine of claim 9, wherein the window includesat least one characteristic selected from the group consisting of: (i)being at least substantially optically transparent; (ii) beingelectrically insulative; (iii) being at least substantially sealed tothe enclosure; and (iv) being at least substantially impact resistant.15. The medical machine of claim 9, which is a dialysis machine.
 16. Amedical machine comprising: an enclosure including an electricallyconductive portion forming a first capacitor plate; a medical devicecomponent located inside the enclosure capable of generatingelectromagnetic energy (“EMI”); a video display with an at leastpartially conductive case forming a second capacitor plate; and adielectric member placed between the first and second capacitor plates,the plates and dielectric member forming a capacitor for preventingleakage of EMI from the medical device component through the enclosure.17. The medical machine in claim 16, wherein the capacitor is alsoconfigured to prevent EMI from outside the medical device from leakinginto the medical device.
 18. The medical machine in claim 16, whichincludes a conductive border contacting edges of the window and theconductive portion of the enclosure, the conductive border and theconductive portion of the enclosure acting as the first capacitor plate.19. The medical machine of claim 16, which includes at least onecharacteristic selected from the group consisting of: (i) the medicaldevice component including a fluid pump; (ii) the window being plastic;(iii) the conductive portion of the enclosure including a conductivemetal coating applied to the enclosure; (iv) the conductive portion ofthe enclosure being a conductive ridge; (v) the dielectric member beingmade of plastic; and (vi) the display configured to display at least oneof text and indicia relating to a therapy provided by the medicalmachine.
 20. The medical machine in claim 16, which includes a windowplaced adjacent to the opening.